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A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Sponsor: Eli Lilly and Company
Summary
The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.
Official title: A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2024-11-18
Completion Date
2027-03
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
Orforglipron
Administered orally. ISA specific interventions will be listed in the ISA.
Placebo
Administered orally. ISA specific interventions will be listed in the ISA.
Locations (117)
University of Arizona
Tucson, Arizona, United States
Loma Linda University School of Medicine
Loma Linda, California, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital of Orange County - Orange
Orange, California, United States
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Oxnard, California, United States
Children's Hospital Colorado
Colorado Springs, Colorado, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
William A. Shands Hospital at the University of Florida
Gainesville, Florida, United States
Florida Hospital- Center for Pediatric Research
Orlando, Florida, United States
Nemours Children's Health
Orlando, Florida, United States
All Childrens Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Norton Children's Endocrinology
Louisville, Kentucky, United States
Velocity Clinical Research
Lafayette, Louisiana, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Helen Devos Childrens' Hospital - PIN
Grand Rapids, Michigan, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
Saint Paul, Minnesota, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport, Mississippi, United States
Sundance Clinical Research
St Louis, Missouri, United States
Omaha Childrens Hospital
Omaha, Nebraska, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
UBMD Pediatrics
Buffalo, New York, United States
UNC Children's Hospital
Chapel Hill, North Carolina, United States
Duke Children's Primary Care
Durham, North Carolina, United States
Lucas Research, Inc
Morehead City, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States
Dell Children's Medical Center - PIN
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
McGovern Medical School
Houston, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
VCU Health - Center for Endocrinology Diabetes and Metabolism
Richmond, Virginia, United States
Seattle Children's Research Institute - Hughes Building - PIN
Seattle, Washington, United States
MultiCare Health System - Mary Bridge Children's Health Center
Tacoma, Washington, United States
UZ Brussel
Brussels, Belgium
Cliniques Universitaires Saint-Luc - PPDS
Brussels, Belgium
UZ Leuven
Leuven, Belgium
L2IP - Instituto de Pesquisas Clínicas
Brasília, Brazil
Hospital Universitario de Caxias do Sul
Caxias do Sul, Brazil
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, Brazil
National Cheng Kung University Hospital
Tainan, China
National Taiwan University Hospital
Taipei, China
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, China
Yitzhak Shamir Medical Center
Beer Yaacov, Israel
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliero Universitaria Meyer
Florence, Italy
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Italy
Saitama Medical University Hospital
Iruma-Gun, Japan
Isesaki Municipal Hospital
Isesaki-shi, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Japan
Tokyo Medical Center
Meguro-Ku, Japan
Shiga General Hospital
Moriyama, Japan
Nara Prefecture General Medical Center
Nara, Japan
Osaka City General Hospital
Osaka, Japan
Sagaekiminami Clinic
Saga, Japan
Shikoku Medical Center for Children and Adults
Zentsujichó, Japan
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
Culiacán, Mexico
PanAmerican Clinical Research - Guadalajara
Guadalajara, Mexico
PanAmerican Clinical Research - Av. Antea 1032 - PPDS
Juriquilla, Mexico
Centro de Investigacion Farmacologica Del Bajio Sc
León, Mexico
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City, Mexico
Hospital Angeles Puebla
Puebla City, Mexico
Krakowskie Centrum Medyczne
Krakow, Poland
UMED Clinical Trials
Lodz, Poland
Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie
Rzeszów, Poland
ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
Stanisławów Pierwszy, Poland
ETG Justmed - PPDS
Warsaw, Poland
Instytut Diabetologii
Warsaw, Poland
FutureMeds - Targowek
Warsaw, Poland
Premium Clinic Wrocław Centrum Medyczne
Wroclaw, Poland
FutureMeds sp. z o. o.
Wroclaw, Poland
Hospital da Luz Lisboa
Lisbon, Portugal
Centro Materno Infantil do Norte
Porto, Portugal
Hospital CUF Porto
Porto, Portugal
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Spain
Instituto Hispalense de Pediatria
Seville, Spain
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
Vitoria-Gasteiz, Spain
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Hull Royal Infirmary - MAIN
Hull, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom